Composition, form of production and packaging
The solution for ingestion, local and external use is transparent, yellow in varying degrees of intensity, a greenish tinge is allowed.
1 f.
sterile purified phagolysate filtrate Klebsiella pneumonia 10 ml
Excipients: 8-hydroxyquinoline sulfate monohydrate 0.0001 g / ml
10 ml - bottles of glass (4) - packs of cardboard.
10 ml - bottles of glass (10) - packs of cardboard.
10 ml - glass bottles (4) - packings of cellular contour (1) - packs cardboard.
The solution for ingestion, local and external use is transparent, yellow in varying degrees of intensity, a greenish tinge is allowed.
1 f.
sterile purified phagolysate filtrate Klebsiella pneumonia 20 ml
Excipients: 8-hydroxyquinoline sulfate monohydrate 0.0001 g / ml
20 ml - bottles of glass (4) - packs of cardboard.
20 ml - bottles of glass (10) - packs of cardboard.
20 ml - glass bottles (4) - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
The drug causes a specific lysis of bacteria Klebsiella pneumoniae.
INDICATIONS
Treatment and prevention of diseases caused by bacteria Klebsiella pneumonia in the complex therapy:
- Diseases of the gastrointestinal tract (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbacteriosis);
- Inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbacteriosis, omphalitis, pemphigus, pyoderma, septicemia and septicopyemia of various locations);
- surgical infections (suppuration of wounds, purulent skin lesions, burns, peritonitis, pleurisy, mastitis, osteomyelitis, abscess);
- urogenital infections (cystitis, pyelonephritis, urethritis, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis);
- purulent inflammatory diseases of the ear, throat, nose, sinuses of the nose, mouth, pharynx, larynx, bronchi, lungs and pleura (otitis, angina, pharyngitis, laryngitis, stomatitis, periodontitis, maxillary sinusitis, frontalitis, bronchitis, pneumonia, pleurisy);
- post-traumatic conjunctivitis, keratoconjunctivitis, purulent corneal ulcer and iridocyclitis;
- Prevention of nosocomial infections caused by Klebsiella.
An important condition for effective phage therapy is the preliminary determination of the pathogenicity of the pathogen.
DOSING MODE
The drug is used for oral administration (through the mouth), in the form of enemas, applications, irrigation, insertion into the wound cavity, vagina, uterus, nose, sinuses of the nose, and also into the drained cavities: abscesses, abdominal, pleural, bladder, renal pelvis.
Inside, the drug is taken on an empty stomach for 0.5-1 hour before meals.
Recommended doses of the drug
Age of the patient Dose for 1 dose for different methods of drug administration
Inside (ml) in enema (ml)
0-6 months 5 10
6-12 months 10 20
From 1 year to 3 years 15 20-30
From 3 to 8 years 20 30-40
From 8 years and older 20-30 40-50
Treatment of purulent-inflammatory diseases with localized lesions should be performed simultaneously, both topically and by ingestion.
In the case of treatment of the purulent focus cavity with chemical antiseptics, before using the bacteriophage, it must be washed with a sterile 0.9% solution of sodium chloride.
In the treatment of angina, pharyngitis, laryngitis, the drug is used to rinse the mouth and throat 3 times a day for 10-20 ml, the course of treatment is 7-10 days.
When treating bronchitis, pneumonia drug is taken 3 times a day for 10-20 ml, and also used as inhalations (without heating and using ultrasound), the course of treatment is 15-20 days.
In the treatment of otitis drug is used to wash and insert into the middle ear cavity 2-5 ml 1-3 times a day. The course of treatment is 7-15 days.
In the treatment of sinus inflammation, the drug is used to wash the nasal cavity, nasopharynx and sinuses in a dose of 5-10 ml and the introduction of 2-3 ml in the sinuses. The procedure is repeated once daily for 7-10 days. In addition, the drug is injected into the nasal cavity in the form of turundas moistened with a bacteriophage, alternately in each nasal passage and left for 0.5-1 hour. The procedure is repeated 3 times a day, the course of treatment is 7-15 days.
In the treatment of stomatitis and chronic generalized periodontitis, the drug is used in the form of mouth rinses 3-4 times a day at a dose of 10-20 ml, as well as by insertion into the periodontal pockets of turunds impregnated with Klebsiella bacteriophage for 5-10 min, the course of treatment is 7-10 days.
With conjunctivitis and keratoconjunctivitis , the drug is used 2-3 drops 4-5 times a day, the course of treatment is 5-7 days; with a purulent ulcer of the cornea - 4-5 drops per day for 7-10 days, with purulent iridocyclitis - 6-8 drops every 3 hours in combination with oral administration in therapeutic dosages for 7-10 days.
With abscesses after opening and removal of purulent contents, the drug is administered in an amount less than the volume of the removed pus daily once, the course of treatment is 7-10 days.
In peritonitis and pleurisy, the drug is injected into the drained cavities-the abdominal and pleural cavities through the drainage tubes once daily, 20-70 ml, and the course of treatment 10-15 days.
In osteomyelitis, the drug is injected into the cavity of the wound through the turundas, drains in the amount of 10-30 ml once a day, the course of treatment is 15-20 days.
In the treatment of wound suppuration, the drug is used in the form of irrigation, applications, bandages, the introduction of a drainage in a dose of 5-50 ml, depending on the lesion less than once a day, the course of treatment 10-15 days.
In the treatment of purulent-inflammatory gynecological diseases (suppuration of wounds, endometritis, vulvitis, bartholinitis, colpitis, salpingoophoritis), the drug is used for irrigation, applications, injected into the wound cavity, vagina, uterus 5-20 ml once a day for 7-10 days.
With cystitis, pyelonephritis, urethritis, the drug is taken orally at a therapeutic dose 3 times a day for 1 hour before meals for 10-20 days. In the event that the cavity of the bladder or renal pelvis is drained, the drug is injected through the cystostomy or nephrostomy 1-3 times a day for 20-50 ml in the bladder and 5-7 ml in the renal pelvis, the course of treatment is 7-15 days.
With gastroenterocolitis, pancreatitis, cholecystitis, and intestinal dysbacteriosis, the bacteriophage is taken orally at age dosages 3 times a day for 1 hour before meals for 7-15 days (according to clinical indications). With indomitable vomiting, the drug is used in the form of high enemas 2-3 times a day for 20-40 ml. With dysbacteriosis of the intestine, the drug can be used with preparations of normoflora.
For prophylaxis of intrahospital surgical infections, the drug is used to treat postoperative and freshly infected wounds in a dose of 5-50 ml, depending on the lesion site, once daily for 5-7 days.
Use of the drug in children under 1 year (including premature infants).
With gastroenterocolitis, pneumonia and sepsis of newborns, the drug is administered through the mouth 2-3 times a day for 3-5 ml 30 minutes before feeding. In cases of uncontrollable vomiting, the drug is used in the form of high enemas (through a gas outlet tube or catheter) daily once in a dose of 5-10 ml. A combination of rectal (in the form of high enemas) and peroral application of the drug is possible. The course of treatment is 7-15 days (according to clinical indications). With a recurring course of the disease, repeated courses of treatment are possible.
In order to prevent the emergence of nosocomial infection in newborns, the bacteriophage is used for epidemiological indications inside by 3-5 ml 3 times a day 30 minutes before feeding during the entire period of stay in the hospital.
In the treatment of omphalitis, pyoderma, infected wounds bacteriophage is applied in the form of applications of 5-10 ml 2-3 times a day (gauze wipe moistened with a bacteriophage and superimposed on the umbilical wound or affected skin area) in
for 7-15 days.
The use of the drug does not exclude the use of other antibacterial and anti-inflammatory drugs.
SIDE EFFECT
Not installed.
CONTRAINDICATIONS
hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The use of this drug during pregnancy and during breast-feeding is possible in the presence of infections caused by phage-sensitive strains of Klebsiella (on the recommendation of a doctor).
APPLICATION FOR CHILDREN
Possible use in children according to indications.
SPECIAL INSTRUCTIONS
Precautions for use
In case of turbidity, do not use the drug!
Due to the content of the nutrient medium in which the bacteria can develop from the environment, causing the drug to cloud, it is necessary to observe the following rules when opening the vial:
- Wash hands thoroughly;
- treat the cap with an alcohol-containing solution;
- remove the cap without opening the plug;
- do not place the inner surface of the cork on a table or other objects;
- do not leave the vial open;
- Store the vial only in the refrigerator.
When using small doses (2-8 drops) the drug should be taken with a sterile syringe in a volume of 0.5-1 ml.
The preparation from the opened bottle under observance of storage conditions, the above rules and absence of turbidity can be used during the whole shelf life.
Impact on the ability to drive vehicles and manage mechanisms
Absent.
OVERDOSE
Not installed.
DRUG INTERACTION
The use of the drug is possible in combination with other drugs, including antibiotics.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
The preparation is stored in accordance with SP 3.3.2.1248-03 in a dry place protected from light and inaccessible to children at a temperature of 2 to 8 В° C. Shelf life - 2 years.
